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| 4 | 4 | | |
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| 5 | 5 | | 2025 -- S 0795 |
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| 6 | 6 | | ======== |
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| 7 | 7 | | LC001819 |
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| 8 | 8 | | ======== |
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| 9 | 9 | | S T A T E O F R H O D E I S L A N D |
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| 10 | 10 | | IN GENERAL ASSEMBLY |
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| 11 | 11 | | JANUARY SESSION, A.D. 2025 |
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| 12 | 12 | | ____________ |
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| 13 | 13 | | |
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| 14 | 14 | | A N A C T |
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| 15 | 15 | | RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCE S ACT |
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| 16 | 16 | | Introduced By: Senators DiMario, Valverde, Lawson, Murray, Euer, Kallman, Britto, and |
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| 17 | 17 | | Lauria |
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| 18 | 18 | | Date Introduced: March 14, 2025 |
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| 19 | 19 | | Referred To: Senate Health & Human Services |
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| 20 | 20 | | |
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| 21 | 21 | | |
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| 22 | 22 | | It is enacted by the General Assembly as follows: |
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| 23 | 23 | | SECTION 1. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled "Uniform 1 |
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| 24 | 24 | | Controlled Substances Act" is hereby amended to read as follows: 2 |
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| 25 | 25 | | 21-28-3.18. Prescriptions. 3 |
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| 26 | 26 | | (a) An apothecary in good faith may sell and dispense controlled substances in schedules 4 |
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| 27 | 27 | | II, III, IV, and V to any person upon a valid prescription by a practitioner licensed by law to 5 |
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| 28 | 28 | | prescribe or administer those substances; dated and signed by the person prescribing on the day 6 |
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| 29 | 29 | | when issued and bearing the full name and address of the patient to whom, or of the owner of the 7 |
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| 30 | 30 | | animal for which, the substance is dispensed; and the full name, address, and registration number 8 |
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| 31 | 31 | | under the federal law of the person prescribing, if he or she is required by that law to be registered. 9 |
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| 32 | 32 | | If the prescription is for an animal, it shall state the species of the animal for which the substance 10 |
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| 33 | 33 | | is prescribed. 11 |
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| 34 | 34 | | (b) When filling a hard-copy prescription for a schedule II controlled substance, the 12 |
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| 35 | 35 | | apothecary filling the prescription shall sign his or her full name and shall write the date of filling 13 |
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| 36 | 36 | | on the face of the prescription. 14 |
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| 37 | 37 | | (c) The prescription shall be retained on file by the proprietor of the pharmacy in which it 15 |
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| 38 | 38 | | was filled for a period of two (2) years so as to be readily accessible for inspection by any public 16 |
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| 39 | 39 | | officer or employee engaged in the enforcement of this chapter. 17 |
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| 40 | 40 | | (d)(1) Hard-copy prescriptions for controlled substances in schedule II shall be filed 18 |
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| 41 | 41 | | separately and shall not be refilled. 19 |
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| 42 | 42 | | |
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| 43 | 43 | | |
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| 44 | 44 | | LC001819 - Page 2 of 8 |
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| 45 | 45 | | (2) The director of health shall, after appropriate notice and hearing pursuant to § 42-35-3, 1 |
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| 46 | 46 | | promulgate rules and regulations for the purpose of adopting a system for electronic data 2 |
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| 47 | 47 | | transmission of prescriptions for controlled substances in schedules II, III, IV, and V. Opioid 3 |
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| 48 | 48 | | antagonists, including, but not limited to, naloxone, as may be further determined by rules and 4 |
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| 49 | 49 | | regulations, shall be transmitted with controlled substances in schedules II, III, IV, and V. Provided, 5 |
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| 50 | 50 | | information collected regarding dispensing of opioid antagonists shall be for statistical, research, 6 |
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| 51 | 51 | | or educational purposes only. The department’s rules and regulations shall require the removal of 7 |
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| 52 | 52 | | patient, recipient, or prescriber information that could be used to identify individual patients or 8 |
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| 53 | 53 | | recipients of opioid antagonists. 9 |
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| 54 | 54 | | (3) A practitioner shall sign and transmit electronic prescriptions for controlled substances 10 |
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| 55 | 55 | | in schedules II, III, IV, and V to a pharmacy in accordance with rules and regulations as shall be 11 |
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| 56 | 56 | | promulgated by the department and which shall require electronic transmission no sooner than 12 |
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| 57 | 57 | | January 1, 2020, and a pharmacy may dispense an electronically transmitted prescription for these 13 |
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| 58 | 58 | | controlled substances in accordance with the code of federal regulations, 21 C.F.R., pt. 1300, et 14 |
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| 59 | 59 | | seq. 15 |
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| 60 | 60 | | (e) Subject to the rules and regulations promulgated by the department pursuant to 16 |
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| 61 | 61 | | subsection (d)(3) of this section, a prescription for a schedule II narcotic substance to be 17 |
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| 62 | 62 | | compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, 18 |
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| 63 | 63 | | subcutaneous, or intraspinal infusion may be transmitted by the practitioner, or practitioner’s agent, 19 |
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| 64 | 64 | | to the pharmacy by facsimile. The facsimile will serve as the original prescription. 20 |
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| 65 | 65 | | (f) Subject to the rules and regulations promulgated by the department pursuant to 21 |
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| 66 | 66 | | subsection (d)(3) of this section, a prescription for a schedule II substance for a resident of a long-22 |
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| 67 | 67 | | term-care facility may be transmitted by the practitioner, or the practitioner’s agent, to the 23 |
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| 68 | 68 | | dispensing pharmacy by facsimile. The facsimile serves as the original prescription. 24 |
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| 69 | 69 | | (g) Subject to the rules and regulations promulgated by the department pursuant to 25 |
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| 70 | 70 | | subsection (d)(3) of this section, a prescription for a schedule II narcotic substance for a patient 26 |
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| 71 | 71 | | residing in a hospice certified by Medicare under title XVIII of the Social Security Act, 42 U.S.C. 27 |
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| 72 | 72 | | § 1395 et seq., or licensed by the state, may be transmitted by the practitioner, or practitioner’s 28 |
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| 73 | 73 | | agent, to the dispensing pharmacy by facsimile. The practitioner, or the practitioner’s agent, will 29 |
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| 74 | 74 | | note on the prescription that the patient is a hospice patient. The facsimile serves as the original, 30 |
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| 75 | 75 | | written prescription. 31 |
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| 76 | 76 | | (h) An apothecary, in lieu of a written prescription, may sell and dispense controlled 32 |
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| 77 | 77 | | substances in schedules III, IV, and V to any person upon an oral prescription of a practitioner. In 33 |
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| 78 | 78 | | issuing an oral prescription, the prescriber shall furnish the apothecary with the same information 34 |
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| 79 | 79 | | |
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| 80 | 80 | | |
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| 81 | 81 | | LC001819 - Page 3 of 8 |
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| 82 | 82 | | as is required by subsection (a) of this section and the apothecary who fills the prescription shall 1 |
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| 83 | 83 | | immediately reduce the oral prescription to writing and shall inscribe the information on the written 2 |
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| 84 | 84 | | record of the prescription made. This record shall be filed and preserved by the proprietor of the 3 |
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| 85 | 85 | | pharmacy in which it is filled in accordance with the provisions of subsection (c) of this section. In 4 |
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| 86 | 86 | | no case may a prescription for a controlled substance listed in schedules III, IV, or V be filled or 5 |
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| 87 | 87 | | refilled more than six (6) months after the date on which the prescription was issued and no 6 |
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| 88 | 88 | | prescription shall be authorized to be refilled more than five (5) times. Each refilling shall be 7 |
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| 89 | 89 | | entered on the face or back of the prescription and note the date and amount of controlled substance 8 |
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| 90 | 90 | | dispensed and the initials or identity of the dispensing apothecary. 9 |
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| 91 | 91 | | (i) In the case of an emergency situation as defined in federal law, an apothecary may 10 |
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| 92 | 92 | | dispense a controlled substance listed in schedule II upon receiving an oral authorization of a 11 |
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| 93 | 93 | | prescribing practitioner provided that: 12 |
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| 94 | 94 | | (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the 13 |
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| 95 | 95 | | patient during the emergency period and dispensing beyond the emergency period must be pursuant 14 |
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| 96 | 96 | | to a written prescription signed by the prescribing practitioner. 15 |
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| 97 | 97 | | (2) The prescription shall be immediately reduced to writing and shall contain all the 16 |
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| 98 | 98 | | information required in subsection (a). 17 |
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| 99 | 99 | | (3) The prescription must be dispensed in good faith in the normal course of professional 18 |
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| 100 | 100 | | practice. 19 |
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| 101 | 101 | | (4) Within seven (7) days after authorizing an emergency oral prescription, the prescribing 20 |
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| 102 | 102 | | practitioner shall cause a prescription for the emergency quantity prescribed to be delivered to the 21 |
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| 103 | 103 | | dispensing apothecary. The prescription shall have written on its face “authorization for emergency 22 |
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| 104 | 104 | | dispensing” and the date of the oral order. The prescription, upon receipt by the apothecary, shall 23 |
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| 105 | 105 | | be attached to the oral emergency prescription that had earlier been reduced to writing. 24 |
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| 106 | 106 | | (j)(1) The partial filling of a prescription for a controlled substance listed in schedule II is 25 |
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| 107 | 107 | | permissible, if the apothecary is unable to supply the full quantity called for in a prescription or 26 |
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| 108 | 108 | | emergency oral prescription and he or she makes a notation of the quantity supplied on the face of 27 |
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| 109 | 109 | | the prescription or oral emergency prescription that has been reduced to writing. The remaining 28 |
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| 110 | 110 | | portion of the prescription may be filled within seventy-two (72) hours of the first partial filling, 29 |
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| 111 | 111 | | however, if the remaining portion is not, or cannot be, filled within seventy-two (72) hours, the 30 |
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| 112 | 112 | | apothecary shall notify the prescribing practitioner. No further quantity may be supplied beyond 31 |
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| 113 | 113 | | seventy-two (72) hours without a new prescription. 32 |
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| 114 | 114 | | (2)(i) A prescription for a schedule II controlled substance written for a patient in a long-33 |
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| 115 | 115 | | term-care facility (LTCF), or for a patient with a medical diagnosis documenting a terminal illness, 34 |
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| 116 | 116 | | |
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| 117 | 117 | | |
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| 118 | 118 | | LC001819 - Page 4 of 8 |
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| 119 | 119 | | may be filled in partial quantities to include individual dosage units. If there is a question whether 1 |
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| 120 | 120 | | a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner 2 |
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| 121 | 121 | | prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have 3 |
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| 122 | 122 | | a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. 4 |
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| 123 | 123 | | (ii) The pharmacist must record on the prescription whether the patient is “terminally ill” 5 |
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| 124 | 124 | | or an “LTCF patient.” A prescription that is partially filled, and does not contain the notation 6 |
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| 125 | 125 | | “terminally ill” or “LTCF patient,” shall be deemed to have been filled in violation of this chapter. 7 |
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| 126 | 126 | | (iii) For each partial filling, the dispensing pharmacist shall record on the back of the 8 |
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| 127 | 127 | | prescription (or on another appropriate record, uniformly maintained, and readily retrievable), the: 9 |
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| 128 | 128 | | (A) Date of the partial filling; 10 |
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| 129 | 129 | | (B) Quantity dispensed; 11 |
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| 130 | 130 | | (C) Remaining quantity authorized to be dispensed; and 12 |
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| 131 | 131 | | (D) Identification of the dispensing pharmacist. 13 |
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| 132 | 132 | | (iv) The total quantity of schedule II controlled substances dispensed in all partial fillings 14 |
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| 133 | 133 | | must not exceed the total quantity prescribed. 15 |
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| 134 | 134 | | (v) Schedule II prescriptions for patients in a LTCF, or patients with a medical diagnosis 16 |
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| 135 | 135 | | documenting a terminal illness, are valid for a period not to exceed sixty (60) days from the issue 17 |
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| 136 | 136 | | date, unless sooner terminated by the discontinuance of medication. 18 |
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| 137 | 137 | | (k) Automated data-processing systems. As an alternative to the prescription record-19 |
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| 138 | 138 | | keeping provision of subsection (h) of this section, an automated data-processing system may be 20 |
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| 139 | 139 | | employed for the record-keeping system if the following conditions have been met: 21 |
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| 140 | 140 | | (1) The system shall have the capability of producing sight-readable documents of all 22 |
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| 141 | 141 | | original and refilled prescription information. The term “sight readable” means that an authorized 23 |
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| 142 | 142 | | agent shall be able to examine the record and read the information. During the course of an on-site 24 |
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| 143 | 143 | | inspection, the record may be read from the CRT, microfiche, microfilm, printout, or other method 25 |
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| 144 | 144 | | acceptable to the director. In the case of administrative proceedings, records must be provided in a 26 |
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| 145 | 145 | | paper printout form. 27 |
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| 146 | 146 | | (2) The information shall include, but not be limited to, the prescription requirements and 28 |
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| 147 | 147 | | records of dispensing as indicated in subsection (h) of this section. 29 |
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| 148 | 148 | | (3) The individual pharmacist responsible for completeness and accuracy of the entries to 30 |
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| 149 | 149 | | the system must provide documentation of the fact that prescription information entered into the 31 |
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| 150 | 150 | | computer is correct. In documenting this information, the pharmacy shall have the option to either: 32 |
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| 151 | 151 | | (i) Maintain a bound logbook, or separate file, in which each individual pharmacist 33 |
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| 152 | 152 | | involved in the dispensing shall sign a statement each day attesting to the fact that the prescription 34 |
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| 153 | 153 | | |
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| 154 | 154 | | |
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| 155 | 155 | | LC001819 - Page 5 of 8 |
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| 156 | 156 | | information entered into the computer that day has been reviewed and is correct as shown. The 1 |
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| 157 | 157 | | book or file must be maintained at the pharmacy employing that system for a period of at least two 2 |
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| 158 | 158 | | (2) years after the date of last dispensing; or 3 |
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| 159 | 159 | | (ii) Provide a printout of each day’s prescription information. That printout shall be 4 |
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| 160 | 160 | | verified, dated, and signed by the individual pharmacist verifying that the information indicated is 5 |
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| 161 | 161 | | correct. The printout must be maintained at least two (2) years from the date of last dispensing. 6 |
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| 162 | 162 | | (4) An auxiliary, record-keeping system shall be established for the documentation of 7 |
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| 163 | 163 | | refills if the automated data-processing system is inoperative for any reason. The auxiliary system 8 |
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| 164 | 164 | | shall ensure that all refills are authorized by the original prescription and that the maximum number 9 |
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| 165 | 165 | | of refills is not exceeded. When this automated data-processing system is restored to operation, the 10 |
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| 166 | 166 | | information regarding prescriptions filled and refilled during the inoperative period shall be entered 11 |
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| 167 | 167 | | into the automated data-processing system within ninety-six (96) hours. 12 |
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| 168 | 168 | | (5) Any pharmacy using an automated data-processing system must comply with all 13 |
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| 169 | 169 | | applicable state and federal laws and regulations. 14 |
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| 170 | 170 | | (6) A pharmacy shall make arrangements with the supplier of data-processing services or 15 |
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| 171 | 171 | | materials to ensure that the pharmacy continues to have adequate and complete prescription and 16 |
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| 172 | 172 | | dispensing records if the relationship with the supplier terminates for any reason. A pharmacy shall 17 |
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| 173 | 173 | | ensure continuity in the maintenance of records. 18 |
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| 174 | 174 | | (7) The automated data-processing system shall contain adequate safeguards for security 19 |
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| 175 | 175 | | of the records to maintain the confidentiality and accuracy of the prescription information. 20 |
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| 176 | 176 | | Safeguards against unauthorized changes in data after the information has been entered and verified 21 |
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| 177 | 177 | | by the registered pharmacist shall be provided by the system. 22 |
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| 178 | 178 | | (l) Prescriptions for controlled substances as found in schedule II will become void unless 23 |
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| 179 | 179 | | dispensed within ninety (90) days of the original date of the prescription and in no event shall more 24 |
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| 180 | 180 | | than a thirty-day (30) supply be dispensed at any one time, with the exception of prescriptions for 25 |
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| 181 | 181 | | non-opioid, non-narcotic controlled substances found in schedule II, where a ninety-day (90) 26 |
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| 182 | 182 | | supply but in no event more than a ninety-day (90) supply, may be dispensed at any one time. 27 |
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| 183 | 183 | | (1) In prescribing controlled substances in schedule II, practitioners may write up to three 28 |
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| 184 | 184 | | (3) separate prescriptions, each for up to a one-month supply, each signed and dated on the date 29 |
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| 185 | 185 | | written. For those prescriptions for the second and/or third month, the practitioner must write the 30 |
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| 186 | 186 | | earliest date each of those subsequent prescriptions may be filled, with directions to the pharmacist 31 |
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| 187 | 187 | | to fill no earlier than the date specified on the face of the prescription. 32 |
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| 188 | 188 | | (m) The prescriptions in schedules III, IV, and V will become void unless dispensed within 33 |
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| 189 | 189 | | one hundred eighty (180) days of the original date of the prescription. For purposes of this section, 34 |
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| 190 | 190 | | |
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| 191 | 191 | | |
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| 192 | 192 | | LC001819 - Page 6 of 8 |
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| 193 | 193 | | a “dosage unit” shall be defined as a single capsule, tablet, or suppository, or not more than one 1 |
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| 194 | 194 | | five (5) ml. of an oral liquid. 2 |
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| 195 | 195 | | (1) Prescriptions in schedule III cannot be written for more than one hundred (100) dosage 3 |
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| 196 | 196 | | units and not more than one hundred (100) dosage units may be dispensed at one time. Provided, 4 |
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| 197 | 197 | | however, manufacturer prepackaged steroids and hormones in schedule III shall be exempt from 5 |
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| 198 | 198 | | this subsection. 6 |
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| 199 | 199 | | (2) Prescriptions in schedules IV and V may be written for up to a ninety-day (90) supply 7 |
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| 200 | 200 | | based on directions. No more than three hundred and sixty (360) dosage units may be dispensed at 8 |
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| 201 | 201 | | one time. 9 |
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| 202 | 202 | | (n) A pharmacy shall transmit prescription information to the prescription-monitoring 10 |
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| 203 | 203 | | database at the department of health within one business day following the dispensing of an opioid 11 |
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| 204 | 204 | | prescription. 12 |
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| 205 | 205 | | (o) The pharmacist shall inform patients verbally or in writing about the proper disposal of 13 |
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| 206 | 206 | | expired, unused, or unwanted medications, including the location of local disposal sites as listed on 14 |
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| 207 | 207 | | the department of health website. 15 |
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| 208 | 208 | | (p) The pharmacist shall inform patients verbally or in writing in the proper use of any 16 |
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| 209 | 209 | | devices necessary for the administration of controlled substances. 17 |
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| 210 | 210 | | (q)(1) A healthcare professional authorized to issue prescriptions shall, prior to issuing an 18 |
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| 211 | 211 | | initial prescription for an opioid drug, specifically discuss with the patient who is eighteen (18) 19 |
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| 212 | 212 | | years of age or older, or the patient’s parent or guardian if the patient is under eighteen (18) years 20 |
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| 213 | 213 | | of age, the risks of developing a dependence or addiction to the prescription opioid drug and 21 |
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| 214 | 214 | | potential of overdose or death; the adverse risks of concurrent use of alcohol or other psychoactive 22 |
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| 215 | 215 | | medications and the patient’s or the minor patient’s parent or guardian’s responsibility to safeguard 23 |
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| 216 | 216 | | all medications; and, if the prescriber deems it appropriate, discuss such alternative treatments as 24 |
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| 217 | 217 | | may be available. For patients in recovery from substance dependence, education shall be focused 25 |
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| 218 | 218 | | on relapse risk factors. This discussion shall be noted in the patient’s record. 26 |
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| 219 | 219 | | (2) The director of the department of health shall develop and make available to prescribers 27 |
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| 220 | 220 | | guidelines for the discussion required pursuant to this subsection. 28 |
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| 221 | 221 | | (3) The discussion required under this subsection shall not be required prior to issuing a 29 |
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| 222 | 222 | | prescription to any patient who is currently receiving hospice care from a licensed hospice. 30 |
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| 223 | 223 | | (r) Effective January 1, 2025, in recognition of the United States Drug Enforcement 31 |
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| 224 | 224 | | Agency (DEA) revised regulations regarding electronic prescription refills permitting DEA 32 |
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| 225 | 225 | | registered pharmacies to transfer electronic prescriptions at a patient’s request, the department of 33 |
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| 226 | 226 | | health shall amend its regulations to reflect this change following the Centers for Medicare and 34 |
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| 227 | 227 | | |
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| 228 | 228 | | |
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| 229 | 229 | | LC001819 - Page 7 of 8 |
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| 230 | 230 | | Medicaid’s designation for the standard the pharmacy industry must use to support Medicare 1 |
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| 231 | 231 | | electronic prescribing and related transactions to permit the transfer of electronic prescriptions. 2 |
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| 232 | 232 | | SECTION 2. This act shall take effect upon passage. 3 |
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| 233 | 233 | | ======== |
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| 234 | 234 | | LC001819 |
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| 236 | 236 | | |
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| 237 | 237 | | |
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| 238 | 238 | | LC001819 - Page 8 of 8 |
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| 239 | 239 | | EXPLANATION |
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| 240 | 240 | | BY THE LEGISLATIVE COUNCIL |
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| 241 | 241 | | OF |
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| 242 | 242 | | A N A C T |
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| 243 | 243 | | RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT |
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| 244 | 244 | | *** |
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| 245 | 245 | | This act would increase the maximum fill for non-opioid, non-narcotic controlled 1 |
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| 246 | 246 | | substances found in schedule II, so that a ninety-day (90) supply may be dispensed at any one time. 2 |
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| 247 | 247 | | This act would take effect upon passage. 3 |
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| 248 | 248 | | ======== |
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| 249 | 249 | | LC001819 |
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| 251 | 251 | | |
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